Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor

K171621 · Welch Allyn, Inc. · MHX · Jun 30, 2017 · Cardiovascular

Device Facts

• Record ID: K171621
• Device Name: Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
• Applicant: Welch Allyn, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 30, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for: - noninvasive blood pressure, - pulse rate. - noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and - body temperature in normal and axillary modes. The most likely locations for patients to be monitored are general medical floors, general hospital, and alternate care environments. The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities. The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities. The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor; end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pentilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring. Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input. The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting. The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement. in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight > 10 Kg) and adults (weight <11 Kg) during sleep and resting condition. The Welch Allyn ECG/Impedance Respiration module and associated software acquires and analyzes ECG signals from patients. Patients are people with coronary problems, suspected coronary problems, or recent medical procedures that require cardiac monitoring. This ECG module can be used on adult and pediatric patients. The ECG module is indicated for use by healthcare professionals whenever there is aneed to monitor a patient's physiological parameters for the following: · ECG - · ECG with alarms for ventricular tachycardia, ventricular fibrillation, and asystole - · Impedance respiration Handle module assembly (Connex Integrated Wall System 8000 series only - Handle Module) - Handles supply power to Welch Allyn 3.5V instruments.

Device Story

Modular patient monitoring system; provides spot-check and continuous monitoring of vital signs. Inputs: NIBP, SpO2, temperature, CO2, respiration rate, heart rate, patient movement, and ECG signals. Transforms inputs via integrated modules (Masimo, Oridion, EarlySense, Global Instruments ECG) into real-time physiological data and alarms. Output: visual display on monitor, data transmission via USB/Ethernet/Wireless to central stations or electronic records. Used in general medical/surgical floors and alternate care settings by clinicians. Benefits: enables continuous patient surveillance, early detection of physiological changes (e.g., cardiac standstill, ventricular tachycardia/fibrillation), and integrated pulmonary status monitoring (IPI).

Clinical Evidence

Bench testing only. No clinical studies utilized. Testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366), alarm systems (IEC 60601-1-8), and performance verification for ECG integration, shock/vibration, thermal stability, and battery life.

Technological Characteristics

Modular system; LCD touch screen; connectivity via USB, Ethernet, wireless. ECG/Impedance Respiration module (Global Instruments). Power: 100-240V AC or Lithium-ion battery. Sterilization: Not supplied sterile. Software: Applications Framework for isolated app execution.

Indications for Use

Indicated for neonatal, pediatric, and adult patients in hospitals, clinics, and alternate care environments for monitoring vital signs including NIBP, pulse rate, SpO2, temperature, CO2, respiration rate, total hemoglobin, and ECG/impedance respiration. Contraindicated for patients on heart/lung machines, transport outside healthcare facilities, MRI environments, hyperbaric chambers, or in presence of flammable anesthetics/electrocautery. ECG module contraindicated for infants <10kg.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Connex® Vital Signs Monitor 6000 Series (K132808)
• Matrix Mini ECG Monitor (K152701)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2017

Welch Allyn, Inc. Mark Alsberge Lead Engineer, Regulatory Affairs 4341 State Street Road Skaneateles Falls, New York 13153

Re: K171621

Trade/Device Name: Welch Allyn Connex Vital Signs Monitor 6000 Series, Welch Allyn Connex Integrated Wall System 80000 Series, 901060 Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MHX, MWI Dated: May 31, 2017 Received: June 2, 2017

Dear Mark Alsberge:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hillebrand

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K171621

#### Device Name

Welch Allyn Connex® Vital Signs Monitor 6000 Series Welch Allyn Connex® Integrated Wall System 80000 Series 901060 Vital Signs Monitor

#### Indications for Use (Describe)

The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

- noninvasive blood pressure,

- pulse rate.
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and

- body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical floors, general hospital, and alternate care environments.

The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor; end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pentilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.

The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.

The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement. in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight > 10 Kg) and adults (weight <11 Kg) during sleep and resting condition.

The Welch Allyn ECG/Impedance Respiration module and associated software acquires and analyzes ECG signals from

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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patients. Patients are people with coronary problems, suspected coronary problems, or recent medical procedures that require cardiac monitoring.

This ECG module can be used on adult and pediatric patients.

The ECG module is indicated for use by healthcare professionals whenever there is aneed to monitor a patient's physiological parameters for the following:

· ECG

- · ECG with alarms for ventricular tachycardia, ventricular fibrillation, and asystole
- · Impedance respiration

Handle module assembly (Connex Integrated Wall System 8000 series only - Handle Module) - Handles supply power to Welch Allyn 3.5V instruments.

This product is available for sale only upon the order of a physician or licensed health care professional.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|------------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span style="font-size: 16px;">☑</span> </div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span style="font-size: 16px;">☐</span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the Welch Allyn logo. The word "Welch" is in green, and the word "Allyn" is in blue. There is a registered trademark symbol to the right of the word "Allyn". The logo is simple and modern.

K171621 Page 1 of 19

Special 510(k) Premarket Notification Connex® Vital Signs Monitor 6000 Series

# 510(k) Summary

[As described in 21 CFR 807.92]

| Submitted by: | Welch Allyn Inc. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 4341 State Street Road |
| | Skaneateles Falls, NY 13153-0220 |
| Contact Person: | Mark Alsberge<br>Lead Regulatory Affairs Engineer<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | May 19, 2017 |
| Trade Name: | Connex® Vital Signs Monitor 6000 Series<br>Connex® Integrated Wall System 80000 Series<br>901060 Vital Signs Monitor |
| Common Name: | monitor, physiological, patient(with arrhythmia detection or alarms) |
| Classification Reference: | Class II, monitor, physiological, patient(with arrhythmia detection or alarms)<br>(21 CFR 870.1025, Product Code MHX) |
| Predicate Device: | Connex® Vital Signs Monitor 6000 Series<br>510(k) Number: K132808<br>monitor,physiological,patient(without arrhythmia detection or alarms), 21 CFR<br>870.2300<br>Class II, MWI<br>Matrix Mini ECG Monitor<br>510(k) Number: K152701<br>Arrhythmia Detector and Alarm (Including ST-Segment Measurement<br>and Alarm), 21 CFR 870.1025<br>Class II, DSL, DRT, BZO |

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Image /page/4/Picture/8 description: The image shows the Hill-Rom logo. The logo is white text on a blue rounded rectangle. The text reads "Hill-Rom."

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Image /page/5/Picture/0 description: The image shows the logo for Welch Allyn. The text "Welch Allyn" is displayed in a combination of green and blue colors. The word "Welch" is in green, while "Allyn" is in blue, with a registered trademark symbol next to it.

## Description of the Device:

The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs spot checking and continuous monitoring.

The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including;

- NIBP Module provides measurements of noninvasive blood pressure and pulse rate,
- SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin,
- The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic ● respiration rate (RRa),
- . The SureTemp Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Temperature can also be measured IR ear thermometer.
- . The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
- The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement.
- The Global Instruments module provides 3 -5 lead ECG/Impedance Respiration. The ECG modules is for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation of this Global Instruments Module is the subject of this 510(k)

The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).

#### Indications for Use:

The Connex® Vital Signs Monitor 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

- noninvasive blood pressure, -
- pulse rate,
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.

The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Enhancing outcomes for patients and their caregivers.

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Image /page/6/Picture/0 description: The image shows the Welch Allyn logo. The word "Welch" is in green, and the word "Allyn" is in blue. There is a registered trademark symbol next to the word "Allyn". The logo is simple and clean.

The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.

The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.

The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition.

The optional ECG/Impedance Respiration System is intended for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tibrillation in general medical and surgical floors, general hospital and professional healthcare facilities. The system is indicated for use in pediativ and adult patients.

This product is available for sale only upon the order of a physician or licensed health care professional.

#### Contraindications:

This system (all configurations) is not intended to be used:

- · on patients connected to heart/lung machines
- on patients being transported outside a healthcare facility
- · within the controlled access area of MRI equipment
- · in a hyperbaric chamber
- · in the presence of flammable anesthetics
- · in the presence of electrocauterization devices

Systems configured with EarlySense are not intended to be used:

- on patients for whom proper positioning cannot be achieved or maintained
- · on patients who do not meet the weight limits tested or specified

Systems configured with a GI ECG module are not intended to be used:

- · The Welch Allyn ECG/Impedance Respiration module is not intended for infants weighing less than 10 Kg (22 lbs) or neonatal patients.
4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Fnhancing outcomes for patients and their caregivers

Image /page/6/Picture/26 description: The image shows the Hill-Rom logo. The logo is white text on a blue rounded rectangle. The text is the company name, "Hill-Rom."

## Section 11 510(k) Summary (per 21 CFR 807.92)

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Image /page/7/Picture/0 description: The image shows the Welch Allyn logo. The words "Welch" are in green, and the words "Allyn" are in blue. The logo is a registered trademark symbol.

- · This module is not designed for direct cardiac application.
- · This module is not suitable for transport.
- · Computer-assisted ECG data acquisition and interpretation is a valuable tool when used properly. However, no automated interpretation is completely reliable. Interpretations should be reviewed by a qualified physician before treatment, or non-treatment, of any patient.

### Technological Characteristics:

The fundamental hardware and mechanical aspects of the CVSM itself remain the same as the predicate CVSM device cleared under K132808 and Global Instruments ECG module cleared under K152701. As noted above, this special 510(k) is for minor software modifications to integrate and display signals from the cleared Global Instruments ECG module on the CVSM system. No changes were made to the Global Instruments ECG technology as cleared; the only changes that are the subject of this submission are the modifications to the CVSM to accommodate integration of the Global Instruments ECG module.

## Non-Clinical Tests:

The Welch Allyn Connex® Vital Signs Monitor 6000 Series was tested to evaluate its safety and effectiveness based on the following standards:

| Standard | Version | Title |
|------------------|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | 2012 | Medical electrical equipment - Part 1: General requirements for basic<br>safety and essential performance |
| EN/IEC 60601-1-2 | 2007 | Medical Electrical Equipment – Part 1-2: General Requirements for<br>Basic Safety and Essential Performance – Collateral Standard:<br>Electromagnetic Compatibility – Requirements and Tests |
| IEC 60601-1-6 | 2010 (3.1 Edition) +<br>A1:2013 | Medical electrical equipment Part 1-6<br>General requirements for safety - Collateral Standard: Usability |
| IEC 62366 | 2007 (First<br>Edition) +<br>A1: 2014 | Medical devices – Application of usability engineering to medical devices |

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Enhancing outcomes for patients and their caregivers

Image /page/7/Picture/13 description: The image shows the Hill-Rom logo. The logo is white text on a blue rounded rectangle. The text reads "Hill-Rom."

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Image /page/8/Picture/0 description: The image shows the Welch Allyn logo. The words "Welch" is in green and "Allyn" is in blue. There is a registered trademark symbol next to the word "Allyn".

Connex® Vital Signs Monitor 6000 Series

| IEC 60601-2-49 | 2011 (2nd<br>Edition) | Medical electrical equipment Part 2-49: Particular requirements for the<br>basic safety and essential performance of multifunction patient monitoring<br>equipment |
|----------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1- 8 | 2006 (Second<br>Edition) +<br>Am.1: 2012 | Medical electrical equipment General requirements for basic safety and<br>essential performance - Collateral standard: General requirements, tests<br>and guidance for alarm systems in medical electrical equipment and<br>medical electrical systems |
| IEC 62304 | 2006 (First<br>Edition) +<br>A1:2015 | Medical Device Software - Software Life Cycle Processes |
| IEC 60601-2-27 | 2011 (Third<br>Edition) | Medical electrical equipment Part 2-27: Particular Requirements for the<br>Safety, Including Essential Performance of Electrocardiographic<br>Monitoring Equipment |
| IEC 80601-2-30 | 2009/AMD1:<br>2013 | Medical Electrical Equipment - Part 2-30: Particular Requirements For<br>The Basic Safety And Essential Performance Of Automated Non-<br>Invasive Sphygmomanometers |
| ISO 80601-2-55 | 2011 (First<br>Edition) | Medical Electrical Equipment - Part 2-55: Particular Requirements For<br>The Basic Safety And Essential Performance Of Respiratory Gas<br>Monitors |
| ISO 80601-2-56 | 2009 (First<br>Edition) | Medical Electrical Equipment - Part 2-56: Particular Requirements For<br>Basic Safety And Essential Performance Of Clinical Thermometers For<br>Body Temperature Measurement. |
| ISO 80601-2-61 | 2011 (First<br>Edition) | Medical electrical equipment - Part 2-61: Particular requirements for<br>basic safety and essential performance of pulse oximeter equipment |
| EN/ISO 14971 | 2007 / (R)<br>2010 | Medical Devices - Application of Risk Management to Medical Devices |

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Enhancing outcomes for
patients and their caregivers:

Image /page/8/Picture/7 description: The image shows the Hill-Rom logo. The logo consists of the words "Hill-Rom" in white text on a blue, rounded rectangle. The text is in a sans-serif font and is centered within the rectangle.

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Image /page/9/Picture/0 description: The image shows the logo for Welch Allyn. The word "Welch" is in green, and the word "Allyn" is in blue. A registered trademark symbol is next to the word "Allyn".

# Additional performance Bench Testing:

| Report --- Description | Objective of the Test | Conclusions |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 60077449<br>Safety Test - CVSM/CIWS<br>Connex Vital Signs Monitor /<br>Connex Integrated Wall System | Test the device per requirements of 60601-1 General<br>Standard, along with associated Collateral and Particular<br>Standards to ensure that the device meets the requirements<br>for Electrical Medical Device Safety | Pass |
| 60082806<br>Electromagnetic Compatibility test<br>CVSM<br>Connex Vital Signs Monitor | Test the device per 60601-1-2 to ensure that the device<br>meets the requirements for Electromagnetic Compatibility | Pass |
| 600829806<br>Electromagnetic Compatibility test<br>CIWS<br>Connex Integrated Wall System | Test the device per 60601-1-2 to ensure that the device<br>meets the requirements for Electromagnetic Compatibility | Pass |
| 60072154 CVSM-CIWS ECG<br>Interface Test. | To verify the ECG module functions when integrated into<br>the platform device.<br>This test is also used to verify ECG Module functions after<br>the system is exposed to the various test conditions below<br>and appears in the criteria column when repeated | PASS |
| 60054591<br>Mobile Stand Threshold | The purpose of this test is to verify that the product is<br>capable of withstanding the stresses caused by rough<br>handling as defined by IEC 60601-1) | Pass |
| 60056145<br>Mobile Stand Tilt | The purpose of this test is to verify that the product is stable<br>on a stand as defined by IEC 60601-1 | Pass |
| 60056145 Shock and Vibration Test | To verify product safety and performance after exposure to<br>shock and vibration. | Pass |
| 60056405<br>Thermal Shock Test | To verify product performance after the thermal shock<br>conditions specified in Applied standards. | Pass |
| 60056431<br>Operating Environmental Test<br>(Temperature and Humidity) | To verify product safety and performance within the<br>specified temperature and humidity environment. | Pass |
| 60056898<br>Ambient Characterization Test | The purpose of this test is ensure that the module level<br>components do not exceed each of their operating<br>temperatures when integrated into the Platform Device and<br>exposed to the operating temperature limits of that device. | Pass |
| 60056476<br>Functional Drop | To verify product safety and performance after exposure to<br>free fall. | Pass |
| 60056426<br>VVP Device Weight Test | To verify the configured Platform device weight. | Pass |
| 60056945<br>Device Ship Test | Ensure device, enclosed in the selected shipping container,<br>meets specifications. | Pass |
| 60042214<br>Battery Use Cycles Per Charge-<br>Continuous Monitoring | Verify that the battery shall operate for a minimum of 2<br>hours under the continuous monitoring use case conditions<br>specified in PMP PAS 60028508 Section 4.4. | Pass |
| 60072092 2 ECG Module<br>Connected to CVSM - Misuse | The purpose of the test is to investigate the behavior of the<br>device after two ECG modules are connected to it.<br>Misuse Testing - reasonably foreseeable misuse use by the<br>operator in a way not intended by the manufacturer but<br>which can result from readily predictable human behavior. | Pass |
| 60082302<br>CVSM-CIWS ECG Patient Cable<br>shorting | The purpose of the test is to investigate the behavior of the<br>device, connected to an ECG module via USB, when the<br>patient cables are all shorted together. This is a common<br>trouble shooting technique with other ECG products to<br>ensure that the patient cable leads are intact.<br>Abuse Testing - reasonably foreseeable abusive use by the<br>operator in a way not intended by the manufacturer but<br>which can result from readily predictable human behavior. | Pass |
| 60042215<br>PMP BOM Verification | The objective of this test is to verify that the released<br>CVSM-ECG BOM includes the specified components<br>identified within the requirements being tested section of<br>this test. This is not a functional test, it is intended as a<br>device inventory to ensure models can be built that will<br>support the features indicated. | Pass |
| 60047144 Thermal Shock - 25<br>cycle | To identify design flaws or behaviors that may occur as a<br>result of the device being exposed to stimulus beyond what<br>is specified within the device thermal shock requirements. | Pass |
| 60082307<br>CIWS ECG Patient Cable Abuse | The purpose of the test is to investigate the behavior of the<br>device, connected to an ECG module via USB, when cables<br>connected to the ECG module are pulled with a force.<br>Abuse Testing - reasonably foreseeable abusive use by the<br>operator in a way not intended by the manufacturer but<br>which can result from readily predictable human behavior. | |
| VVR 60082325 For 60072367<br>CVSM ECG USB and Patient Cable<br>Abuse | The purpose of the test is to investigate the behavior of the<br>device, connected to an ECG module via USB, when cables<br>connected to the ECG module are pulled with a force.<br>Abuse Testing - reasonably foreseeable abusive use by the<br>operator in a way not intended by the manufacturer but<br>which can result from readily predictable human behavior. | |
| 60082350 for 60072546 ECG<br>Device List | This protocol verifies that WAST (WelchAllyn Service<br>Tool) lists the ECG device with CVSM connected via USB,<br>and updates when any device is added or removed | |
| VVR 60082506 For 60082431<br>CVSM ECG ACM Mount<br>Reliability Test. | Test the Reliability of ECG module mounting to repeated<br>use | |

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

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Image /page/10/Picture/0 description: The image shows the Welch Allyn logo. The word "Welch" is in green, and the word "Allyn" is in blue. There is a registered trademark symbol to the right of the word "Allyn". The logo is simple and professional.

Image /page/10/Picture/6 description: The image features the Hill-Rom logo. The logo consists of the text "Hill-Rom" in a bold, sans-serif font. The text is white and is set against a light blue, rounded rectangle.

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Image /page/11/Picture/0 description: The image shows the Welch Allyn logo. The words "Welch" are in green, and "Allyn" are in blue. There is a registered trademark symbol next to the word "Allyn". The logo is simple and clean.

K171621 Page 8 of 19

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Image /page/11/Picture/6 description: The image shows the Hill-Rom logo. The logo consists of the words "Hill-Rom" in white text on a blue, rounded rectangle. The text is bold and sans-serif. The logo is simple and modern.

Section 11 510(k) Summary (per 21 CFR 807.92)

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Image /page/12/Picture/0 description: The image shows the Welch Allyn logo. The word "Welch" is in green, and the word "Allyn" is in blue. There is a registered trademark symbol to the right of the word "Allyn". The logo is simple and professional.

## Clinical Performance Data:

No clinical studies were utilized for the purpose of obtaining safety and effectiveness data.

### Device Comparison Table:

The Welch Allyn Connex® Vital Signs Monitor 6000 Series is substantially equivalent in operation and performance to the Welch Allyn Vital Signs Monitor 6000 Series monitor (K121013).

| Subject Device and Predicate Device Comparison | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate Devices | Subject Device | Differences |
| Device Name | Connex® VSM 6000 Series<br>and<br>Matrix Mini ECG Monitor | Connex® VSM 6000 Series | Same<br>Added ECG<br>Module |
| Manufacturer | Welch Allyn, Inc.,<br>and<br>Global Instrumentation ,<br>LLC | Welch Allyn, Inc., | Same - Welch<br>Allyn will be<br>distributor of<br>ECG Module |
| 510(k) Number | K132808<br>K152701 | N/A | N/A |
| Product Code | MWI<br>DSI, DRT, BZQ | MHX | Update with<br>addition of<br>ECG module |
| Regulation Name | 870.2300 - Cardiac monitor<br>(including<br>cardiotachometer and rate<br>alarm)<br>870.1025 - Arrhythmia<br>Detector and Alarm<br>(Including ST-Segment<br>Measurement<br>and Alarm) | 870.1025 – monitor,<br>physiological, patient(with<br>arrhythmia detection or<br>alarms) | Update with<br>addition of<br>ECG module |
| Indications For Use | Welch Allyn Connex ® VSM<br>6000 Series<br>The VSM 6000 series of<br>monitors is intended to be<br>used by clinicians and<br>medically qualified personnel<br>for monitoring of neonatal,<br>pediatric, and adult patients | Welch Allyn Connex ® VSM<br>6000 Series<br>The VSM 6000 series of<br>monitors is intended to be<br>used by clinicians and<br>medically qualified personnel<br>for monitoring of neonatal,<br>pediatric, and adult patients | |
| Subject Device and Predicate Device Comparison | | | |
| Characteristic | Predicate Devices | Subject Device | Differences |
| | for: | for: | |
| |…